Process Development Associate in San Diego

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Job Description

Job Summary

• Primarily responsible for commercial manufacturing. Also responsible for the transfer of manufacturing processes from R&D to Manufacturing and continuous improvement of existing processes.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Maintains the Pilot Plant laboratory under cGMP conditions.

• Produces development, pilot, and production materials per written instructions.

• Completes ERP transactions.

• Stocks and maintains the laboratory supplies.

• Keeps accurate records and documentation.

• Completes laboratory work and associated paperwork by assigned completion dates.

• Produces notebook materials per written instructions.

• Develops manufacturing processes for transfer to Manufacturing.

• Assists with execution of process validation of new and existing manufacturing processes.

• Improves manufacturing processes.

• Completes cycle counts.

• Washes lab ware.

Qualifications

Education

• Bachelor’s degree (sciences)

Experience

• 1+ years’ experience

Skills

• Basic knowledge of QMS (Quality Management System)/GMP requirements

Must follow all applicable FDA regulations and ISO requirements.

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